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GMP-Updates - ALK-2026


Description

Welcome to the 2025 GMP-update!

  • It contains 8 modules between 4 and 13 minutes
  • After each module you will answer one question to finish the module and can start the next.
  • When you have finished all the modules you will be able to download a certificate.
  • The certificate will be available until end of January 2026.
  • Srart Module 1 to get going. You can stop after any Module and continue later.

Start Date:

Content
  • Introduction
  • Module 1 - GMP for MAH
  • Module 2 - GMP for IMP
  • Module 3 - ICH Quality Risk Management
  • Module 4 - FDA and EU inspection statistics
  • Module 5 - Investigtions and RCA
  • Module 6 - FDA Remote Regulatory Assessments
  • Module 7 - FDA Quality Management Maturity
  • Module 8 - New EU Pharma Legislation
  • Module 9 - Annex 11 and Annex 22
  • Knowledge test - 10 Questions
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: 2 years